Job Description
Job Description
Job Title : Medical Records Specialist
Location - 8200 Coral Sea Street NE, Mounds View, MN, 55112
Payrate - $28.57/hour on W2
Duration - 24 months
Job Description -
- Apply policies and procedures to comply with FDA and OUS regulations.
- Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
- Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
- Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
- Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
- Maintain awareness of new products, government regulations and requirements.
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
- Other duties as assigned.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor of science degree
- High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)
- 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Have
- Degree in nursing, biology/pre-med or pre-vet, or biomedical engineering
- Medical device industry experience
- Strong verbal and written communication skills
- Knowledge of basic anatomy and physiology
- Strong attention to detail
- High level of computer proficiency